THR-687, a diabetic macular edema treatment candidate, was shown to be safe and well tolerated in a phase 1 trial, Oxurion announced in a press release.
The open-label, multicenter, single dose escalation study evaluated the safety of a single intravitreal injection of three increasing doses (0.4 mg, 1 mg and 2.5 mg) of THR-687, a novel pan-RGD integrin antagonist.
Patients in all dosing groups experienced improvement in mean best corrected visual acuity after a single injection. Mean BCVA improved 3.1 letters on day 1, with 9.2 letters of improvement recorded at month 1 and a mean improvement of 8.3 letters at month 3.
The highest dose level showed the greatest effect on both BCVA, with a mean improvement of 11 letters on day 14 and 12.5 letters at month 3, as well as a peak mean central subfield thickness decrease of 106 µm on day 14, the release said.
“We are delighted by these encouraging topline data, which confirm that our integrin antagonist THR-687 is not only well tolerated and safe for intravitreal use, but could be effective in inducing a rapid and sustained gain in BCVA in patients with DME,” Patrik De Haes, MD, Oxurion CEO, said in the release. “We are also pleased to see a clinically meaningful reduction in mean CST with our highest dose in this patient population, following just one single injection.”
A phase 2 study of THR-687 in treatment-naive DME patients is planned for the second half of 2020.